Trial Outcomes & Findings for A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors (NCT NCT02697591)
NCT ID: NCT02697591
Last Updated: 2021-02-26
Results Overview
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent AE is any AE either reported for first time or worsening of a pre-existing event after the first dose of study drug. Grade 1 AEs is defined as Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 AEs is defined as Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 AEs is defined as the severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living and Grade 4 AEs as life-threatening consequences; urgent intervention indicated. Data is reported for Grade 3 and higher severity for this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
100 participants
Primary outcome timeframe
From screening through 60 days after end of treatment, up to Month 15
Results posted on
2021-02-26
Participant Flow
A total of 100 participants were enrolled at 7 study sites in the United States from 20 June 2016 to 16 December 2019.
Participant milestones
| Measure |
Phase 1: 0.03 mg/kg Q2W
Participants received intravenous (IV) infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
3
|
15
|
18
|
16
|
4
|
10
|
22
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
2
|
2
|
0
|
1
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
3
|
13
|
16
|
16
|
3
|
9
|
20
|
Reasons for withdrawal
| Measure |
Phase 1: 0.03 mg/kg Q2W
Participants received intravenous (IV) infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
1
|
7
|
6
|
9
|
1
|
6
|
10
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
2
|
3
|
1
|
1
|
4
|
5
|
3
|
1
|
1
|
5
|
|
Overall Study
Reason not Specified
|
0
|
0
|
0
|
1
|
1
|
2
|
3
|
1
|
1
|
3
|
Baseline Characteristics
A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
INCAGN01876 was administered at 0.03mg/kg Q2W as part of dose escalation.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
INCAGN01876 was administered at 0.1mg/kg Q2W as part of dose escalation.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
INCAGN01876 was administered at 0.3mg/kg Q2W as part of dose escalation.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
INCAGN01876 was administered at 1.0mg/kg Q2W as part of dose escalation.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
INCAGN01876 was administered at 3mg/kg Q2W as part of dose escalation.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
INCAGN01876 was administered at 5mg/kg Q2W as part of dose escalation.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
INCAGN01876 was administered at 10mg/kg Q2W as part of dose escalation.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
INCAGN01876 was administered at 20mg/kg Q2W as part of dose escalation.
|
Phase 1: 400 mg Q4W
n=10 Participants
INCAGN01876 was administered at 400mg Q4W as part of dose escalation.
|
Phase 2: 300 mg Q2W
n=22 Participants
INCAGN01876 was administered at 300mg Q2W as part of dose escalation.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 17.02 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 21.01 • n=7 Participants
|
70.0 years
STANDARD_DEVIATION 12.19 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 14.93 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 10.58 • n=21 Participants
|
53.6 years
STANDARD_DEVIATION 12.83 • n=10 Participants
|
62.3 years
STANDARD_DEVIATION 10.22 • n=115 Participants
|
59.5 years
STANDARD_DEVIATION 14.75 • n=24 Participants
|
57.6 years
STANDARD_DEVIATION 12.02 • n=42 Participants
|
67.2 years
STANDARD_DEVIATION 10.86 • n=42 Participants
|
60.1 years
STANDARD_DEVIATION 13.23 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
58 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
92 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
82 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African-American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
ECOG Performance Status
0
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
|
ECOG Performance Status
1
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
ECOG Performance Status
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
ECOG Performance Status
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
ECOG Performance Status
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
ECOG Performance Status
5
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From screening through 60 days after end of treatment, up to Month 15Population: The full analysis set (FAS) included all participants enrolled in the study who received at least 1 dose of study drug.
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent AE is any AE either reported for first time or worsening of a pre-existing event after the first dose of study drug. Grade 1 AEs is defined as Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 AEs is defined as Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 AEs is defined as the severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living and Grade 4 AEs as life-threatening consequences; urgent intervention indicated. Data is reported for Grade 3 and higher severity for this outcome measure.
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity
TEAEs
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
15 Participants
|
18 Participants
|
16 Participants
|
4 Participants
|
10 Participants
|
22 Participants
|
|
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity
Grade 3 and Higher
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
11 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 6 post-dosePopulation: The pharmacokinetic (PK) evaluable population included all participants who received at least 1 dose of study drug and provided at least 1 post dose sample (1 PK measurement).
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Cycle 1 (After the First Dose)
|
781 nanograms per millilitre (ng/mL)
Standard Deviation 135
|
2700 nanograms per millilitre (ng/mL)
Standard Deviation 779
|
6450 nanograms per millilitre (ng/mL)
Standard Deviation 1330
|
21,600 nanograms per millilitre (ng/mL)
Standard Deviation 321
|
66,000 nanograms per millilitre (ng/mL)
Standard Deviation 13,700
|
128,000 nanograms per millilitre (ng/mL)
Standard Deviation 30,100
|
283,000 nanograms per millilitre (ng/mL)
Standard Deviation 71,500
|
437,000 nanograms per millilitre (ng/mL)
Standard Deviation 60,500
|
127,000 nanograms per millilitre (ng/mL)
Standard Deviation 25,400
|
103,000 nanograms per millilitre (ng/mL)
Standard Deviation 25,600
|
|
Maximum Observed Plasma Concentration (Cmax)
Cycle 6
|
—
|
—
|
7420 nanograms per millilitre (ng/mL)
Standard Deviation 573
|
36,500 nanograms per millilitre (ng/mL)
Standard Deviation NA
Standard deviation was not estimable due to low number of participants analyzed.
|
107,000 nanograms per millilitre (ng/mL)
Standard Deviation 25,500
|
176,000 nanograms per millilitre (ng/mL)
Standard Deviation 65,700
|
409,000 nanograms per millilitre (ng/mL)
Standard Deviation 97,000
|
—
|
168,000 nanograms per millilitre (ng/mL)
Standard Deviation 28,500
|
137,000 nanograms per millilitre (ng/mL)
Standard Deviation 21,900
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 6 post-dosePopulation: The PK evaluable population included all participants who received at least 1 dose of study drug and provided at least 1 post dose sample (1 PK measurement).
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax)
Cycle 1 (After the First Dose)
|
0.1 hours (hr)
Interval 0.1 to 0.1
|
0.1 hours (hr)
Interval 0.1 to 0.1
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 0.1
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
|
Time to Maximum Concentration (Tmax)
Cycle 6
|
—
|
—
|
0.1 hours (hr)
Interval 0.1 to 0.1
|
4.0 hours (hr)
Lower and upper limits were not estimable due to low number of participants analyzed.
|
0.1 hours (hr)
Interval 0.1 to 0.1
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
—
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
0.1 hours (hr)
Interval 0.1 to 4.0
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 2, 3, 4, 6, and 7 post-dosePopulation: The PK evaluable population included all participants who received at least 1 dose of study drug and provided at least 1 post dose sample (1 PK measurement). Data is presented for those cycles for which data is available.
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Cycle 2
|
42.1 ng/mL
Standard Deviation 48.8
|
460 ng/mL
Standard Deviation 131
|
1110 ng/mL
Standard Deviation 762
|
4910 ng/mL
Standard Deviation 1420
|
14,800 ng/mL
Standard Deviation 6160
|
25,600 ng/mL
Standard Deviation 12,100
|
58,000 ng/mL
Standard Deviation 23,900
|
95,400 ng/mL
Standard Deviation 33,300
|
13,000 ng/mL
Standard Deviation 10,100
|
22,800 ng/mL
Standard Deviation 5880
|
|
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Cycle 7
|
—
|
0.0 ng/mL
Standard Deviation 0.0
|
939 ng/mL
Standard Deviation 1060
|
15,500 ng/mL
Standard Deviation NA
Standard deviation could not be calculated for single patient
|
41,100 ng/mL
Standard Deviation 16,700
|
64,900 ng/mL
Standard Deviation 34,800
|
124,000 ng/mL
Standard Deviation 42,100
|
—
|
27,500 ng/mL
Standard Deviation 18,300
|
63,400 ng/mL
Standard Deviation 53,500
|
|
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Cycle 3
|
0.0 ng/mL
Standard Deviation 0.0
|
206 ng/mL
Standard Deviation 187
|
900 ng/mL
Standard Deviation 1050
|
8290 ng/mL
Standard Deviation 5530
|
23,500 ng/mL
Standard Deviation 10,600
|
36,200 ng/mL
Standard Deviation 25,500
|
89,200 ng/mL
Standard Deviation 35,000
|
117,000 ng/mL
Standard Deviation 44,400
|
22,800 ng/mL
Standard Deviation 10,200
|
36,800 ng/mL
Standard Deviation 16,300
|
|
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Cycle 4
|
0.0 ng/mL
Standard Deviation 0.0
|
29.1 ng/mL
Standard Deviation 50.5
|
1390 ng/mL
Standard Deviation 1230
|
10,300 ng/mL
Standard Deviation NA
Standard deviation could not be calculated for single patient
|
25,700 ng/mL
Standard Deviation 15,000
|
46,700 ng/mL
Standard Deviation 36,500
|
135,000 ng/mL
Standard Deviation 73,700
|
135,000 ng/mL
Standard Deviation 66,300
|
20,500 ng/mL
Standard Deviation 11,200
|
31,600 ng/mL
Standard Deviation 15,200
|
|
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Cycle 6
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
1210 ng/mL
Standard Deviation 1260
|
15,100 ng/mL
Standard Deviation NA
Standard deviation could not be calculated for single patient
|
34,900 ng/mL
Standard Deviation 19,000
|
71,800 ng/mL
Standard Deviation 42,800
|
133,000 ng/mL
Standard Deviation 33,200
|
—
|
21,300 ng/mL
Standard Deviation 14,100
|
42,400 ng/mL
Standard Deviation 15,600
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 6 post-dosePopulation: The PK evaluable population included all participants who received at least 1 dose of study drug and provided at least 1 post dose sample (1 PK measurement).
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)
Cycle 1 (After the First Dose)
|
70.7 microgram (μg)*hr/mL
Standard Deviation 29.0
|
302 microgram (μg)*hr/mL
Standard Deviation 115
|
850 microgram (μg)*hr/mL
Standard Deviation 108
|
3130 microgram (μg)*hr/mL
Standard Deviation 254
|
8880 microgram (μg)*hr/mL
Standard Deviation 2710
|
17,900 microgram (μg)*hr/mL
Standard Deviation 4970
|
39,800 microgram (μg)*hr/mL
Standard Deviation 10,300
|
67,500 microgram (μg)*hr/mL
Standard Deviation 7920
|
25,400 microgram (μg)*hr/mL
Standard Deviation 10,000
|
13,400 microgram (μg)*hr/mL
Standard Deviation 3520
|
|
Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)
Cycle 6
|
—
|
—
|
1070 microgram (μg)*hr/mL
Standard Deviation 392
|
7190 microgram (μg)*hr/mL
Standard Deviation NA
Standard deviation was not estimable due to low number of participants analyzed.
|
16,200 microgram (μg)*hr/mL
Standard Deviation 10,000
|
33,700 microgram (μg)*hr/mL
Standard Deviation 17,400
|
79,000 microgram (μg)*hr/mL
Standard Deviation 13,400
|
—
|
42,100 microgram (μg)*hr/mL
Standard Deviation 19,500
|
22,000 microgram (μg)*hr/mL
Standard Deviation 6640
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 monthsPopulation: The FAS included all participants enrolled in the study who received at least 1 dose of study drug.
ORR is defined as the percentage of participants having complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease assessments. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm.
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)
mRECIST v1.1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
25.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)
RECIST v1.1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
25.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 monthsPopulation: The FAS included all participants enrolled in the study who received at least 1 dose of study drug.
DOR is defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm.
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) Per RECIST and mRECIST
RECIST v1.1
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
169.0 Days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with response
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable
|
NA Days
There was 1 participant with response, but DOR was ongoing at time of censoring, which was 399 days after initial response.
|
|
Duration of Response (DOR) Per RECIST and mRECIST
mRECIST v1.1
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
169.0 Days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with response
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There were no participants with response at given timepoint thus median and 95% CI was not estimable.
|
NA Days
There was 1 participant with response, but DOR was ongoing at time of censoring, which was 399 days after initial response.
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 monthsPopulation: The FAS included all participants enrolled in the study who received at least 1 dose of study drug.
Duration of disease control (CR, PR, and stable disease \[SD\]), as measured from first report of SD or better until disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Disease Control Per RECIST and mRECIST
mRECIST v1.1
|
NA days
There were no participants with stable disease or response at given timepoint thus median and 95% CI was not estimable
|
NA days
There were no participants with stable disease or response at given timepoint thus median and 95% CI was not estimable
|
169.0 days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with stable disease or response
|
91.0 days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with stable disease or response
|
58.5 days
Interval 36.0 to 226.0
|
58.0 days
Interval 53.0 to 109.0
|
62.0 days
Interval 59.0 to 113.0
|
61.0 days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with stable disease or response
|
113.0 days
Interval 15.0 to 172.0
|
213.0 days
Interval 54.0 to
Upper limit of 95% CI was not estimable as there were not enough participants with stable disease or response.
|
|
Duration of Disease Control Per RECIST and mRECIST
RECIST v1.1
|
NA days
There were no participants with stable disease or response at given timepoint thus median and 95% CI was not estimable.
|
NA days
There were no participants with stable disease or response at given timepoint thus median and 95% CI was not estimable
|
169.0 days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with stable disease or response
|
91.0 days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with stable disease or response
|
58.5 days
Interval 36.0 to 226.0
|
58.0 days
Interval 53.0 to 109.0
|
62.0 days
Interval 59.0 to 113.0
|
61.0 days
Lower and upper limits of 95% CI were not estimable as there were not enough participants with stable disease or response
|
113.0 days
Interval 15.0 to 172.0
|
213.0 days
Interval 54.0 to
Upper limit of 95% CI was not estimable as there were not enough participants with stable disease or response.
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 monthsPopulation: The FAS included all participants enrolled in the study who received at least 1 dose of study drug.
PFS is defined as the time from date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. Progression is defined by RECIST and mRECIST as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute lesion increase of at least 5 mm or the appearance of new lesions.
Outcome measures
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 Participants
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 Participants
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 Participants
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 Participants
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 Participants
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 Participants
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 Participants
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Per RECIST and mRECIST
PFS under RECIST v1.1
|
1.64 months
Interval 0.89 to 1.84
|
1.84 months
Interval 0.53 to 1.84
|
6.70 months
Interval 1.64 to 11.04
|
1.48 months
Interval 1.18 to 4.7
|
1.87 months
Interval 0.72 to 3.68
|
1.87 months
Interval 1.48 to 3.61
|
1.84 months
Interval 0.95 to 3.58
|
2.78 months
Interval 0.76 to 3.75
|
2.14 months
Interval 1.74 to 5.55
|
1.87 months
Interval 1.68 to 3.61
|
|
Progression Free Survival (PFS) Per RECIST and mRECIST
PFS under mRECIST v1.1
|
1.64 months
Interval 0.89 to 1.84
|
1.84 months
Interval 0.53 to 1.84
|
6.70 months
Interval 1.64 to 11.04
|
1.48 months
Interval 1.18 to 4.7
|
1.87 months
Interval 0.72 to 3.68
|
1.87 months
Interval 1.48 to 3.61
|
1.84 months
Interval 0.95 to 3.58
|
2.78 months
Interval 0.76 to 3.75
|
2.14 months
Interval 1.74 to 5.55
|
1.87 months
Interval 1.68 to 3.61
|
Adverse Events
Phase 1: 0.03 mg/kg Q2W
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1: 0.1 mg/kg Q2W
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: 0.3 mg/kg Q2W
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1: 1.0 mg/kg Q2W
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: 3.0 mg/kg Q2W
Serious events: 6 serious events
Other events: 15 other events
Deaths: 4 deaths
Phase 1: 5.0 mg/kg Q2W
Serious events: 6 serious events
Other events: 18 other events
Deaths: 5 deaths
Phase 1: 10.0 mg/kg Q2W
Serious events: 7 serious events
Other events: 16 other events
Deaths: 3 deaths
Phase 1: 20.0 mg/kg Q2W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1: 400 mg Q4W
Serious events: 3 serious events
Other events: 10 other events
Deaths: 1 deaths
Phase 2: 300 mg Q2W
Serious events: 10 serious events
Other events: 22 other events
Deaths: 5 deaths
Total
Serious events: 43 serious events
Other events: 99 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 participants at risk
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 participants at risk
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 participants at risk
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 participants at risk
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 participants at risk
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 participants at risk
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Total
n=100 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Chills
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Fatigue
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
18.2%
4/22 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
10/100 • Number of events 10 • From screening through 60 days after end of treatment, up to Month 15
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Hydronephrosis
|
25.0%
1/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Perforation
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Pyelonephritis
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Septic shock
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
Other adverse events
| Measure |
Phase 1: 0.03 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 0.03 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.1 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 0.1 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 0.3 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 0.3 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 1.0 mg/kg Q2W
n=3 participants at risk
Participants received IV infusion of study drug at a dose of 1.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 3.0 mg/kg Q2W
n=15 participants at risk
Participants received IV infusion of study drug at a dose of 3.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 5.0 mg/kg Q2W
n=18 participants at risk
Participants received IV infusion of study drug at a dose of 5.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 10.0 mg/kg Q2W
n=16 participants at risk
Participants received IV infusion of study drug at a dose of 10.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 20.0 mg/kg Q2W
n=4 participants at risk
Participants received IV infusion of study drug at a dose of 20.0 mg/kg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Phase 1: 400 mg Q4W
n=10 participants at risk
Participants received IV infusion of study drug at a dose of 400 mg Q4W starting on Day 1 of each cycle for up to 15 months.
|
Phase 2: 300 mg Q2W
n=22 participants at risk
Participants received IV infusion of study drug at a dose of 300 mg Q2W starting on Day 1 of each cycle for up to 15 months.
|
Total
n=100 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Social circumstances
Denture wearer
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
16.7%
3/18 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
7.0%
7/100 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Local swelling
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Localised oedema
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Malaise
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
18.2%
4/22 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
7.0%
7/100 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
3/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
27.8%
5/18 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
37.5%
6/16 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
2/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
22.7%
5/22 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
24.0%
24/100 • Number of events 29 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Nodule
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
3/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
27.8%
5/18 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
22.7%
5/22 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
16.0%
16/100 • Number of events 18 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.0%
6/100 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
5/15 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
27.8%
5/18 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
18.8%
3/16 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
17.0%
17/100 • Number of events 19 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
3/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
2/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
8.0%
8/100 • Number of events 8 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
31.2%
5/16 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
18.2%
4/22 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
19.0%
19/100 • Number of events 22 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
6.0%
6/100 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
25.0%
1/4 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
8.0%
8/100 • Number of events 12 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
3/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.0%
6/100 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Systemic infection
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
6.0%
6/100 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
3/15 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
16.7%
3/18 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
31.2%
5/16 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
19.0%
19/100 • Number of events 24 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
66.7%
2/3 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
3/15 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
16.7%
3/18 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
8/16 • Number of events 9 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
2/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
22.0%
22/100 • Number of events 25 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
8.0%
8/100 • Number of events 8 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
22.2%
4/18 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
18.8%
3/16 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
18.2%
4/22 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
15.0%
15/100 • Number of events 16 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Anhedonia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
16.7%
3/18 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
8.0%
8/100 • Number of events 8 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Asthenia
|
50.0%
2/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Axillary pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
9.0%
9/100 • Number of events 10 • From screening through 60 days after end of treatment, up to Month 15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
18.8%
3/16 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
10/100 • Number of events 10 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Chest pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Chills
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
27.8%
5/18 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
11.0%
11/100 • Number of events 11 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
26.7%
4/15 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
22.7%
5/22 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
13.0%
13/100 • Number of events 15 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
26.7%
4/15 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
18.8%
3/16 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
30.0%
3/10 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
18.2%
4/22 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
20/100 • Number of events 21 • From screening through 60 days after end of treatment, up to Month 15
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
2/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
9.0%
9/100 • Number of events 10 • From screening through 60 days after end of treatment, up to Month 15
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
16.7%
3/18 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.0%
6/100 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
20.0%
3/15 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
22.2%
4/18 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
15.0%
15/100 • Number of events 20 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
6.0%
6/100 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
66.7%
2/3 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
40.0%
6/15 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
22.2%
4/18 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
18.8%
3/16 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
30.0%
3/10 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
22.7%
5/22 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
24.0%
24/100 • Number of events 26 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Face oedema
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Fatigue
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
40.0%
6/15 • Number of events 6 • From screening through 60 days after end of treatment, up to Month 15
|
27.8%
5/18 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
43.8%
7/16 • Number of events 8 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
5/10 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
11/22 • Number of events 12 • From screening through 60 days after end of treatment, up to Month 15
|
38.0%
38/100 • Number of events 40 • From screening through 60 days after end of treatment, up to Month 15
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
7.0%
7/100 • Number of events 7 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Globulins increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Grip strength decreased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
50.0%
2/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
22.2%
4/18 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
12.0%
12/100 • Number of events 13 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
33.3%
1/3 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
12.5%
2/16 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
8.0%
8/100 • Number of events 8 • From screening through 60 days after end of treatment, up to Month 15
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
11.1%
2/18 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
5.0%
5/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 5 • From screening through 60 days after end of treatment, up to Month 15
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
4.0%
4/100 • Number of events 4 • From screening through 60 days after end of treatment, up to Month 15
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
2.0%
2/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
6.7%
1/15 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
13.6%
3/22 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
7.0%
7/100 • Number of events 8 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
6.2%
1/16 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
10.0%
1/10 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
|
Gastrointestinal disorders
Lip swelling
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/15 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
1.0%
1/100 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/3 • From screening through 60 days after end of treatment, up to Month 15
|
13.3%
2/15 • Number of events 2 • From screening through 60 days after end of treatment, up to Month 15
|
5.6%
1/18 • Number of events 1 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/16 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/10 • From screening through 60 days after end of treatment, up to Month 15
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to Month 15
|
3.0%
3/100 • Number of events 3 • From screening through 60 days after end of treatment, up to Month 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER